Improving the acceptability of the atrial defibrillator: patient-activated cardioversion versus automatic night cardioversion with and without sedation (ADSAS 2).

Acceptability of the atrial defibrillator is partly limited by concerns about shock related anxiety and discomfort. Sedation and/or automatic cardioversion therapy during sleep may ease shock discomfort and improve patient acceptability. Three atrial cardioversion techniques were compared: patient-activated cardioversion with sedation, automatic night cardioversion with sedation, and automatic night cardioversion without sedation. Sedation was oral midazolam (15 mg). Fifteen patients aged 60 +/- 13 years were assigned each strategy randomly for three consecutive episodes of persistent atrial fibrillation requiring cardioversion. Patients completed questionnaires for multiple parameters immediately and again at 24 hours postcardioversion. Atrial cardioversion strategies with oral sedation (patient-activated and automatic) significantly reduced shock recall by 77% (P < 0.005), therapy dissatisfaction by 57%-71% (P < 0.03), shock discomfort by 61%-73% (P < 0.01), shock pain by 79%-83% (P < 0.001), and shock intensity by 73%-77% (P < 0.03), compared to automatic night cardioversion without sedation (P < 0.02). Atrial shock pain was short-lived and caused little disruption to the patients' daily routines. Automatic night cardioversion without sedation, resulted in sleep disturbances not seen with the other strategies (42% vs 0%, P < 0.001) as well as concerns about future pain or discomfort. Twelve patients (80%) chose patient-activated cardioversion with sedation as their preferred treatment, and three (20%) remainder chose automatic night cardioversion with sedation. Ninety percent of patients chose automatic night cardioversion without sedation as the least acceptable therapy. Sedation significantly increases atrial shock acceptability regardless of cardioversion method. Shocks without sedation are significantly less acceptable to patients using the atrial defibrillators.

RCT Entities:   Population Interventions Outcomes